In April 2022, Swissmedic started design work on the swissdamed database. The name stands for "swiss database on medical devices ".
swissdamed will provide an overview of the life cycle of medical devices available in Switzerland. The database will integrate various IT systems which can be used to gather and process information about medical devices and the companies concerned (e.g. manufacturers). Like EUDAMED, swissdamed thereby aims to increase overall transparency, in particular by improving access to information by the public and by healthcare professionals.
swissdamed will consist of two modules and a public website. In addition to the registered operators (from August 2024), medical devices (voluntarily from 2025) will also be registered on the database in future. As the objective is to ensure equivalence between Swiss and EU regulations, swissdameds structure will be similar to the corresponding EUDAMED modules. Economic operators who have already registered with Swissmedic, and have therefore been assigned a CHRN, will not need to register again; they will have to check their data once these have been imported into swissdamed. During the registration process, Swissmedic will inform the stated contact person by letter about what happens next.
swissdamed will be rolled out in stages. The first release will cover the registration of economic operators. A second release will enable registration of certain medical devices. Subsequent releases will complete the Devices module.
All relevant specifications / additional information will be published on this page.
Device registration will become compulsory only when the relevant amendments are made to the MedDO / IvDO.